Investigations are an inevitable aspect of any manufacturer’s or wholesaler’s operations. We share some common issues seen at inspections so you can consider your own company’s systems and practices and improve investigation outcomes.
Have you ever thought about becoming an MHRA inspector but wanted to know more about the role, the application process, or the benefits associated with joining a talented and dynamic team protecting public health? Part one of this two-part blog will hopefully give you the information you need to consider for applying for future roles.
Between 11 to 14 February 2020, the MHRA will be hosting a week-long series of events as part of the Good Practice Symposia Week. The week will include individual events from GPvP, GCP and GLP Inspectorates
The annual GCP Symposium was held by the MHRA on 11 September 2019 in Manchester. The symposium focused on non-commercial organisations (Trusts/Health Boards/University sponsors, Charities and investigator sites) and covered a variety of topics.
A principle objective of both the MHRA and of pharmaceutical companies is to protect and improve the health of patients. When new information about the benefits and risks of a medicine become available it is often appropriate to make changes to the safety information for the product.
The GXP environment is evolving as digital technologies are increasingly being applied to the development and manufacture of medicines.
On Tuesday 7 May 2019 representatives from trade organisations, professional bodies, non-commercial organisations and other regulators and government functions involved in the analysis of clinical trial laboratory samples were invited to attend the inaugural GCP Laboratories Stakeholder Engagement Meeting (StEM) …
The MHRA Good Manufacturing/Good Distribution Practice Symposium will be held in London on the 11 to 14 November and in Glasgow on 26 to 27 November 2019. This post details how to secure your place and provides some information about what each of the sessions will include.
On 28 October 2019 the GCP inspectorate will be holding a roundtable discussion aimed at suppliers of electronic health records in both primary and secondary care (including commercial and non-commercial developers). This post details how to register your attendance for this event.
Details and links for new licence applications and variations.
Theft of medicines increases risk to public health - a look at what can be done to improve distribution security standards.